The responsible pharmacist or any other person licensed to dispense in terms of the Medicines Act, shall supervise the safety, security, purchasing, storage, and dispensing of medicines in a hospital.
| (a) |
An updated manual reflecting all relevant policies must be available. All pharmacy personnel must have a sound knowledge thereof and apply policies accordingly. |
| (b) |
Short, medium and long-term planning for an effective and cost-effective pharmaceutical service should be done on a regular basis with priorities set out within financial and personnel structures. |
| (c) |
The responsible pharmacist must be responsible for the annual estimates and budgets for medicine, and should take all the necessary measures to, as far as possible, ensure that expenditure remains within the budget. |
| (d) |
Data for statistical analysis and financial information must be gathered and regular reports be made reflecting the methods employed to economise. |
| (e) |
Lines of authority and areas of responsibility must be clearly defined and conform to labour legislation. |
| (f) |
A manual with Standard Operating Procedures governing all pharmacy functions must be prepared and revised in accordance with changing circumstances and needs. All pharmacy personnel must be familiar with the contents of such a manual and must practise in accordance with the manual. |
| (g) |
Cost-effective and service-orientated work schedules, systems and procedures which utilise pharmacy personnel and resources most effectively should be instituted and subjected to regular re-evaluation and in this way establish an acceptable standard of practice. |
| (h) |
Policies and procedures must be developed for the provision of, or access to a pharmacy service on a twenty-four-hour basis. Content of emergency cupboards and the supplying of medicine by persons other than pharmacists must be reduced to the absolute minimum and must be fully controlled by the pharmacy. |
| (i) |
Medicines must only be provided for dispensing by persons other than pharmacists if such persons are duly licensed to dispense in terms of the Medicines Act. |
| (j) |
The pharmacy must be represented on and actively involved in all appropriate hospital committees (e.g. the Infection Control Committee, Pharmacy and Therapeutics Committee, the Management Committee and the Financial Committee) where such committees exist. |
| (k) |
Regular staff meetings of pharmacists must be held. Such meetings will promote improved administration and service. |
| (l) |
The hospital pharmacy or institution must establish its own professional quality assurance committee. Quality assurance cannot be acquired without collaboration with other health care professionals for those areas of mutual responsibility. |
| 4.3.2 |
Pharmacy and therapeutic committees |
| (a) |
The Pharmacy and Therapeutics Committee(s) has the primary purpose of advising and educating professional staff on all matters pertinent and relevant to the use of medical products in the hospital environment. |
| (b) |
Regular liaison must be maintained to develop policies and procedures relating to the selection and the rational, safe and effective use of medical products, surgical dressings and medicine administration systems within the hospital's boundaries. |
| (c) |
The Pharmacy and Therapeutics Committee(s) must be a multi-disciplinary focal point for all policy decisions relating to the control of medicines within the hospital environment. |
| (d) |
Membership must be representative and could comprise (where available) clinicians (at least one physician and one surgeon), pharmacists, a nursing representative, and may also include a management representative, a junior hospital doctor and a general practitioner. Other disciplines may be included to reflect local requirements. |
| (e) |
Terms of reference could include: |
| (i) |
the development of medicine policies; |
| (ii) |
the approval of a local formulary; |
| (iii) |
the pursuit of safety and economy in the use of medicines and prevention of medicine abuse; |
| (iv) |
the provision of information on medicine costs and efficacy; |
| (v) |
the monitoring of medicine use and expenditure; and |
| (vi) |
the provision of information on new medicines. |
| 4.3.3 |
Adverse reaction reporting |
Adverse drug reaction reporting must be done in accordance with the guidelines for reporting adverse drug reactions in South Africa as published by the MCC (GN R7659 of 2 May 2003).
| 4.3.4 |
Managing formularies, clinical guidelines and treatment protocols |
The effective management of formularies, clinical guidelines and treatment protocols promotes rational use of drug therapy in groups of patients. This important component of medicine resource management aims to improve the safety, efficacy and efficiency of medicine use in patient populations.
| (a) |
A local formulary is a compilation of medicines approved for use within the hospital/institution and must reflect the current judgement of clinicians and pharmacists on the basis of efficacy, safety and costs. The formulary must be produced in co-operation with the Pharmacy and Therapeutics Committee. |
| (b) |
The minimum requirements for a formulary must be a written list of approved medicines classified according to therapeutic use. The formulary can also contain: |
| (i) |
information on the method of use of the formulary; |
| (ii) |
local procedures governing the prescribing of medicines; |
| (iii) |
relevant pharmaceutical policies and procedures controlling medicine distribution; |
| (iv) |
advice on the selection of medicines from within the formulary; |
| (v) |
information on special aspects on the use of medicines; |
| (vi) |
the procedure for amending the formulary; |
| (vii) |
the procedure for obtaining a non-formulary item for an individual patient. |
| (c) |
There must be agreed procedures for medicines to be added to, or deleted from the formulary. |
| (d) |
The responsible pharmacist must update, maintain and monitor the formulary system on behalf of the Pharmacy and Therapeutics Committee. |
| 4.3.5 |
Minimum standards for visits by pharmaceutical representatives |
Pharmaceutical representatives can play an important role in the introduction and marketing of medicinal products in hospitals/institutions. They can also provide a valuable educational service and supply up-to-date information on the latest developments in the pharmaceutical field. It is therefore in the interest and to the benefit of hospitals if representatives and the responsible pharmacist work together closely.
The following standards apply to visits by representatives:
| (a) |
Representatives on their first visit to a hospital/institution must consult with the responsible pharmacist on the internal rules and regulations regarding visits by pharmaceutical representatives to the particular hospital, as procedures may vary. |
| (b) |
Representatives must only visit a hospital/institution by appointment and the pharmacist must be kept fully informed as to the programme of appointment, meetings, etc. that representatives may have in the hospital/institution, including visits to be made to the pharmacy department, for the detailing of products. |
| (c) |
Representatives must inform the responsible pharmacist of any new products before detailing to other personnel. |
| (d) |
Representatives must liaise with the responsible pharmacist to determine the policy to be used for the supply of medicines for clinical trials or medicine evaluations. |
| (e) |
Representatives must not be permitted access to pharmacy stock, medicine cupboards, etc. for any reason. |
| (f) |
Derogatory and inflammatory remarks about competitors' products, companies, the award of tenders and personnel must be avoided. |
| (g) |
Representatives must be aware that it is a privilege and not a right to conduct business in hospitals/institutions and must at all times be sensitive to the working pressures and environment of personnel. |
| 4.3.6 |
Minimum standards for continuous supply of medicines |
| (a) |
A community and institutional pharmacy must have a pharmacist available to provide a pharmaceutical service to the public on a 24-hour basis. |
| (b) |
If a pharmacy is not open on a 24-hour basis, a designated pharmacist(s) must be available for the emergency supply of pharmaceutical services. |
| (c) |
Contact details of the pharmacist-on-duty must be displayed conspicuously at the pharmacy premises. |
Statistics Act, 1999
